Hypermobile EDS (hEDS)NCT07626957
Hamstring Strengthening in Hypermobile Conditions
A study testing Progressive resistance exercise with an emphasis on eccentric hamstring loading. in people with Hypermobile EDS (hEDS) and Hypermobile Ehlers-Danlos Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder
- What is being tested?
- Progressive resistance exercise with an emphasis on eccentric hamstring loading.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reported diagnosis of HSD or hEDS by a physician
- Meet the 2017 International Diagnostic Criteria for HSD and hEDS
- Clearance to participant in exercise participation, determined using the Get Active Questionnaire
Who cannot join
- Other acquired or hereditary connective tissue disorder (i.e., rheumatoid arthritis, Marfan syndrome, etc.)
- Currently experiencing daily knee pain
- Prior knee injury or surgery
- Intra-articular knee injection in the last 12 months
- Currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Calgary - Foothills Campus
Calgary, Alberta, T2N 4N1
Ranita Manocha, bettermobilitylab@ucalgary.ca
Ranita Manocha, MD, MSc
About this study
Official title: Effects and Feasibility of Eccentric Hamstring Strengthening in Hypermobility Spectrum Disorders and Hypermobile Ehlers-Danlos Syndrome
The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). The main questions it aims to answer are:
- Does hamstring strengthening reduce the looseness of the knee joint in HSD/hEDS?
- Does hamstring strengthening improve clinical outcomes like pain in people living with HSD/hEDS?
Participants will:
- Attend two exercise classes per week for 12 weeks.
- Visit the laboratory every 4-6 weeks for testing.
Read the detailed description
Hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) affect 1 in 500 people, predominantly females. While exercise is known to be beneficial for HSD/hEDS, the effect of eccentric exercise on passive joint stability, the functional capacity to perform daily activities, and quality of life remains unknown. This clinical trial aims to determine the effects of a 12-week eccentric hamstring strengthening intervention for females with HSD/hEDS on knee joint laxity, performance during walking and stair climbing, and quality of life. This study will have important implications for understanding the impacts of exercise in HSD/hEDS. This can then inform clinical guidance and recommendations around lower limb exercise for this population.
- Conditions
- Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Hypermobility Type Ehlers-Danlos Syndrome
- Being tested
- Progressive resistance exercise with an emphasis on eccentric hamstring loading.
- Keywords
- Exercise, Female, Knee, Joint Laxity, Hypermobility, Joint Stiffness, Ehlers-Danlos Syndrome, Hypermobile Ehlers-Danlos Syndrome, Hypermobility Spectrum Disorders, strengthening, eccentric
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Motor Activity, Joint Instability, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance exercise with an emphasis on eccentric hamstring loading.Behavioural
Also called Exercise, Progressive Resistance Training, Eccentric Exercise
The exercise intervention consists of a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. This program is adapted from a lower limb progressive resistance training protocol that was well-tolerated and effective in people with HSD/hEDS. Each exercise session will start with a 10-minute aerobic warm up. This will be followed by the lower limb strengthening exercises, and a 5-minute aerobic cooldown. The lower limb exercises will include forward lunges and seated machine weights (leg press, leg extension, leg curl, calf raise). At weeks 6-11, eccentric hamstring loading will be initiated by utilizing the 2:1 technique of two limbs performing concentric action at once and then a single limb performing the eccentric action in a seated leg curl machine. This is an established eccentric loading protocol for the hamstring muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric hamstring exercise | Experimental | All participants will complete a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. Participants will complete two training sessions per week with at least 48 hours between training sessions. Multiple classes will be offered each week to increase participation opportunity, with morning classes (8-9am) and evening classes (6-7pm) being offered on Mondays and Thursdays. Each class will be led by the same trained kinesiologist and cover the same training protocol within a given week, regardless of the day or time. Receives: Behavioral: Progressive resistance exercise with an emphasis on eccentric hamstring loading. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Laxity
Anterior knee joint laxity measured in millimeters using a KT-2000 Knee Ligament Arthrometer at 67N, 89N, and 133N of applied force, as well as maximum displacement. Posterior knee joint laxity will be assessed at 67N of applied force. Changes in knee joint laxity at each level of applied force will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Secondary outcomes (8)
Knee Joint Stiffness
Anterior knee joint stiffness calculated from the change in displacement divided by the change in force from 0N to 67N, 67N to 89N, and 89N to 133N. Posterior knee joint stiffness will be calculated between 0N and 67N of force. Changes in stiffness will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic eccentric knee flexion strength
Isokinetic eccentric knee flexion strength at 60 degrees per second will be measured using a Biodex Dynamometer. Change in eccentric knee flexion strength will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic concentric knee flexion strength
Isokinetic concentric knee flexion strength at 60 degrees per second will be measured using a Biodex dynamometer. Change in concentric knee flexion strength will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Hamstrings:Quadriceps Co-Activation
Co-activation between the hamstrings and quadriceps muscles will be measured using Delsys surface electromyography sensors during dynamometry, the 6-Minute Walk Test, and the stair climb test. Changes in hamstring:quadriceps co-activation will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
6-Minute Walk Test
Functional capacity/performance will be assessed using the 6-Minute Walk Test, which measures the distance in meters that a participant can walk in 6 minutes. Changes in performance will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Pain Severity Score
Pain severity score (from 0 to 40) will be calculated from the pain severity components of the Brief Pain Inventory. The Brief Pain Inventory is a questionnaire that measures the location of pain (body diagram), pain severity (4 questions with numeric rating scales from 0-10, 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine"), medications or treatments, a numeric rating scale (0-100%, 0% indicating "no relief" and 100% indicating "complete relief") for relief of pain from medications or treatments, as well as pain interference (7 questions with numeric rating scales from 0-10, 0 indicating "does not interfere" and 10 indicating "completely interferes"). Changes in pain severity score will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
Measured: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Safety of the Intervention
Safety of the intervention will be monitored and determined by the number of adverse events reported by participants to either the exercise kinesiologist during the exercise sessions, or to the research team during data collection or via email.
Measured: Monitored throughout the study from baseline to 24 weeks.
Tolerability of the Intervention
Tolerability of the exercise intervention will be assessed using the following metrics: Number of participants that withdraw from the study (along with reasons for withdrawal), number of exercises classes completed after 12 weeks, and pain severity (100mm visual analog scale) before and after each exercise class.
Measured: Monitored throughout the study, from baseline to week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile EDS (hEDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranita Manocha, University of Calgary
- Investigators
- Ranita Manocha, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626957
- Sponsor's protocol ID
- REB26-0442
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Feasibility of Eccentric Hamstring Strengthening in Hypermobility Spectrum Disorders and Hypermobile Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT07626957
- Acronym / sponsor ID
- REB26-0442
- Conditions
- Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Hypermobility Type Ehlers-Danlos Syndrome
- Keywords
- Exercise, Female, Knee, Joint Laxity, Hypermobility, Joint Stiffness, Ehlers-Danlos Syndrome, Hypermobile Ehlers-Danlos Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). The main questions it aims to answer are:
- Does hamstring strengthening reduce the looseness of the knee joint in HSD/hEDS?
- Does hamstring strengthening improve clinical outcomes like pain in people living with HSD/hEDS?
Participants will:
- Attend two exercise classes per week for 12 weeks.
- Visit the laboratory every 4-6 weeks for testing.
Detailed description
Hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) affect 1 in 500 people, predominantly females. While exercise is known to be beneficial for HSD/hEDS, the effect of eccentric exercise on passive joint stability, the functional capacity to perform daily activities, and quality of life remains unknown. This clinical trial aims to determine the effects of a 12-week eccentric hamstring strengthening intervention for females with HSD/hEDS on knee joint laxity, performance during walking and stair climbing, and quality of life. This study will have important implications for understanding the impacts of exercise in HSD/hEDS. This can then inform clinical guidance and recommendations around lower limb exercise for this population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eccentric hamstring exercise | Experimental | Behavioral: Progressive resistance exercise with an emphasis on eccentric hamstring loading.All participants will complete a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. Participants will complete two training sessions per week with at least 48 hours between training sessions. Multiple classes will be offered each week to increase participation opportunity, with morning classes (8-9am) and evening classes (6-7pm) being offered on Mondays and Thursdays. Each class will be led by the same trained kinesiologist and cover the same training protocol within a given week, regardless of the day or time. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Reported diagnosis of HSD or hEDS by a physician
- Meet the 2017 International Diagnostic Criteria for HSD and hEDS
- Clearance to participant in exercise participation, determined using the Get Active Questionnaire
Key exclusion criteria (5 listed)
- Other acquired or hereditary connective tissue disorder (i.e., rheumatoid arthritis, Marfan syndrome, etc.)
- Currently experiencing daily knee pain
- Prior knee injury or surgery
- Intra-articular knee injection in the last 12 months
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance exercise with an emphasis on eccentric hamstring loading.Also: Exercise, Progressive Resistance Training, Eccentric ExerciseThe exercise intervention consists of a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. This program is adapted from a lower limb progressive resistance training protocol that was well-tolerated and effective in people with HSD/hEDS. Each exercise session will start with a 10-minute aerobic warm up. This will be followed by the lower limb strengthening exercises, and a 5-minute aerobic cooldown. The lower limb exercises will include forward lunges and seated machine weights (leg press, leg extension, leg curl, calf raise). At weeks 6-11, eccentric hamstring loading will be initiated by utilizing the 2:1 technique of two limbs performing concentric action at once and then a single limb performing the eccentric action in a seated leg curl machine. This is an established eccentric loading protocol for the hamstring muscle group. | Behavioural | Eccentric hamstring exercise |
Primary outcome
Knee Joint Laxity
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Anterior knee joint laxity measured in millimeters using a KT-2000 Knee Ligament Arthrometer at 67N, 89N, and 133N of applied force, as well as maximum displacement. Posterior knee joint laxity will be assessed at 67N of applied force. Changes in knee joint laxity at each level of applied force will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.
8 secondary outcomes
Knee Joint Stiffness
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic eccentric knee flexion strength
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic concentric knee flexion strength
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Hamstrings:Quadriceps Co-Activation
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
6-Minute Walk Test
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Pain Severity Score
Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Safety of the Intervention
Time frame: Monitored throughout the study from baseline to 24 weeks.
Tolerability of the Intervention
Time frame: Monitored throughout the study, from baseline to week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hypermobile EDS (hEDS)
Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Recruiting
STABLE Pilates for Hypermobility
Ehlers-Danlos Syndrome (EDS), Hypermobile EDS (hEDS)
Enrolling by invitation
TMD-specific Physiotherapy in hEDS Patients Individuals With Hypermobile Ehlers-Danlos Syndrome
Hypermobile Ehlers-Danlos Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ranita Manocha principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance exercise with an emphasis on eccentric hamstring loading. in people with Hypermobile EDS (hEDS) and Hypermobile Ehlers-Danlos Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ranita Manocha (4039444224, bettermobilitylab@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Joint Laxity (time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.